FDA.reportPublic FDA data

CVS Pharmacy Nighttime Severe Cough and Cold

Product NDC
59779-221
11-digit product format
597790221
Labeler code
59779
Product ID
59779-221_c73f9aba-85ae-4825-9fd4-572d4f28bc89
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
CVS Pharmacy
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-03-25
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-221-062020-01-31C16284748780-19d75b9d0-5be7-f424-e053-dadaa90a57ceCVS Pharmacy Nighttime Severe Cough and Cold Honey lemon infused with Chamomile and White tea flavors

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-221-06CVS Pharmacy Nighttime Severe Cough and Coldhoney lemon infused with chamomile and white tea flavors6 in 1 BOXGRANULE, FOR SOLUTION64

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DCVS PHARMACY NIGHTTIME SEVERE COUGH AND COLD HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CVS PHARMACY]4
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40CVS PHARMACY NIGHTTIME SEVERE COUGH AND COLD HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CVS PHARMACY]4
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJCVS PHARMACY NIGHTTIME SEVERE COUGH AND COLD HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CVS PHARMACY]4
AcetaminophenACTIVE MOIETY362O9ITL9DCVS PHARMACY NIGHTTIME SEVERE COUGH AND COLD HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CVS PHARMACY]4
DiphenhydramineACTIVE MOIETY8GTS82S83MCVS PHARMACY NIGHTTIME SEVERE COUGH AND COLD HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CVS PHARMACY]4
PhenylephrineACTIVE MOIETY1WS297W6MVCVS PHARMACY NIGHTTIME SEVERE COUGH AND COLD HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CVS PHARMACY]4
AcesulfameINACTIVE INGREDIENTMA3UYZ6K1HCVS PHARMACY NIGHTTIME SEVERE COUGH AND COLD HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CVS PHARMACY]4
AspartameINACTIVE INGREDIENTZ0H242BBR1CVS PHARMACY NIGHTTIME SEVERE COUGH AND COLD HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CVS PHARMACY]4
Citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCVS PHARMACY NIGHTTIME SEVERE COUGH AND COLD HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CVS PHARMACY]4
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DCVS PHARMACY NIGHTTIME SEVERE COUGH AND COLD HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CVS PHARMACY]4
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRCVS PHARMACY NIGHTTIME SEVERE COUGH AND COLD HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CVS PHARMACY]4
SucroseINACTIVE INGREDIENTC151H8M554CVS PHARMACY NIGHTTIME SEVERE COUGH AND COLD HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CVS PHARMACY]4
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCVS PHARMACY DAYTIME NIGHTTIME SEVERE COLD AND COUGH KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) KIT [CVS PHARMACY]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCVS PHARMACY DAYTIME NIGHTTIME SEVERE COLD AND COUGH KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) KIT [CVS PHARMACY]3
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40CVS PHARMACY DAYTIME NIGHTTIME SEVERE COLD AND COUGH KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) KIT [CVS PHARMACY]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCVS PHARMACY DAYTIME NIGHTTIME SEVERE COLD AND COUGH KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) KIT [CVS PHARMACY]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCVS PHARMACY DAYTIME NIGHTTIME SEVERE COLD AND COUGH KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) KIT [CVS PHARMACY]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCVS PHARMACY DAYTIME NIGHTTIME SEVERE COLD AND COUGH KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) KIT [CVS PHARMACY]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCVS PHARMACY DAYTIME NIGHTTIME SEVERE COLD AND COUGH KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) KIT [CVS PHARMACY]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCVS PHARMACY DAYTIME NIGHTTIME SEVERE COLD AND COUGH KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) KIT [CVS PHARMACY]3
ACESULFAMEINACTIVE INGREDIENTMA3UYZ6K1HCVS PHARMACY DAYTIME NIGHTTIME SEVERE COLD AND COUGH KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) KIT [CVS PHARMACY]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1CVS PHARMACY DAYTIME NIGHTTIME SEVERE COLD AND COUGH KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) KIT [CVS PHARMACY]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCVS PHARMACY DAYTIME NIGHTTIME SEVERE COLD AND COUGH KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) KIT [CVS PHARMACY]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCVS PHARMACY DAYTIME NIGHTTIME SEVERE COLD AND COUGH KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) KIT [CVS PHARMACY]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCVS PHARMACY DAYTIME NIGHTTIME SEVERE COLD AND COUGH KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) KIT [CVS PHARMACY]3
SUCROSEINACTIVE INGREDIENTC151H8M554CVS PHARMACY DAYTIME NIGHTTIME SEVERE COLD AND COUGH KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) KIT [CVS PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-221CVS PHARMACY NIGHTTIME SEVERE COUGH AND COLD HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CVS PHARMACY]4Legacy NDC, 1 package rows20130401_3e059551-39ce-45d1-8cc4-fdd76135544f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659960acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN3e059551-39ce-45d1-8cc4-fdd76135544f4
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD3e059551-39ce-45d1-8cc4-fdd76135544f4
1659960acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSY3e059551-39ce-45d1-8cc4-fdd76135544f4
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSY3e059551-39ce-45d1-8cc4-fdd76135544f4
1659960APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY3e059551-39ce-45d1-8cc4-fdd76135544f4
1428880{1 (acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) } PackGPCKce1b51d0-25b3-43d9-924d-293b3b5eaeb23
14288801 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packets for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Packets for Oral Solution) PackPSNce1b51d0-25b3-43d9-924d-293b3b5eaeb23
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNce1b51d0-25b3-43d9-924d-293b3b5eaeb23
1659960acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNce1b51d0-25b3-43d9-924d-293b3b5eaeb23
1659967acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDce1b51d0-25b3-43d9-924d-293b3b5eaeb23
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDce1b51d0-25b3-43d9-924d-293b3b5eaeb23
14288801 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packets for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packets for Oral Solution) PackSYce1b51d0-25b3-43d9-924d-293b3b5eaeb23
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral SolutionSYce1b51d0-25b3-43d9-924d-293b3b5eaeb23
1659960acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSYce1b51d0-25b3-43d9-924d-293b3b5eaeb23
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSYce1b51d0-25b3-43d9-924d-293b3b5eaeb23
1659967APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYce1b51d0-25b3-43d9-924d-293b3b5eaeb23
1659960APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYce1b51d0-25b3-43d9-924d-293b3b5eaeb23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
59779-221-06597790221066 in 1 BOXHistorical